U.S. patent number 5,215,522 [Application Number 07/682,165] was granted by the patent office on 1993-06-01 for single use medical aspirating device and method.
This patent grant is currently assigned to Ballard Medical Products. Invention is credited to Larry E. Page, Darrel Palmer.
United States Patent |
5,215,522 |
Page , et al. |
June 1, 1993 |
Single use medical aspirating device and method
Abstract
A reliable, contamination-resistant, single-use, disposable,
medical, non-ventilating, aspirating device and method. The device
releasibly connects to and aligns with an indwelling endotracheal
tube to accommodate advancing of an aspirating catheter tube of the
device by manual manipulation through a sterile, flexible envelope
and selective evacuation of lung secretions through a closed and
sterile two-position, normally-closed, manually-operable valve at
the proximal end of the device, while simultaneously accommodating
voluntarily respiration by the patient.
Inventors: |
Page; Larry E. (Sandy, UT),
Palmer; Darrel (Sandy, UT) |
Assignee: |
Ballard Medical Products
(Draper, UT)
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Family
ID: |
27534249 |
Appl.
No.: |
07/682,165 |
Filed: |
April 5, 1991 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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28805 |
Mar 23, 1987 |
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917866 |
Oct 14, 1986 |
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916341 |
Oct 7, 1986 |
4696296 |
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767400 |
Aug 20, 1985 |
4638539 |
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633570 |
Jul 23, 1984 |
4569344 |
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Current U.S.
Class: |
604/33; 604/35;
604/118; 604/163; 604/241; 251/318; 137/903; 251/336; 251/335.2;
251/331; 128/207.16 |
Current CPC
Class: |
A61M
1/86 (20210501); A61M 16/0463 (20130101); A61M
16/0465 (20130101); A61M 1/7413 (20210501); A61M
25/0111 (20130101); Y10S 137/903 (20130101) |
Current International
Class: |
A61M
16/04 (20060101); A61M 1/00 (20060101); A61M
25/01 (20060101); A61M 001/00 () |
Field of
Search: |
;128/207.16,200.26,207.14,207.15
;604/33,35,118,119,159,163,167,171,249,27,28,30,32,34,246,248,250
;251/331,335.2,318,336,346-368 ;137/903 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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3307517 |
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Sep 1984 |
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DE |
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560910 |
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Jul 1924 |
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FR |
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Other References
"Side Eye Position", a report concerning suction kits and
catheters; Davel Products (undated). .
Cathmark, item of literature (Date unknown). .
Superior Brochure "Continuous Ventilating Suction System"
(undated). .
Superior Advertisement "Infection Control Valve Suction Catheter"
(undated). .
Suctioning of left bronchial tree in the intubated adult, Care
Medicine, Kamiaru; 092 (Date Unknown). .
Evaluation of Selective Bronchial Suctioning Techniques Used for
Infants and Children, Anesthesiology, 48:379-380 (date unknown).
.
ACMI Catalog, pp. 31-35, Copyright 1960. .
Prevention of hypoxic Complication. 1968. .
"Sterile suctioning with bare hands.", The Nation's Hospitals &
Diagnostic Laboratories, Fall 1975. .
Comparison of Tracheobronchial Suction Catheters in Humans, Chest,
vol. 69, pp. 179-181, Feb. 1976. .
Selective tracheobronchial aspiration, Thorax, 32, 346-348, 1977.
.
Efficon Trach Care Brochure and Price List, Apr. 15, 1978. .
A new controllable suction catheter for blind cannulation of the
main stem brochi, Critical Care Medicine, vol. 6, No. 5, Sep.-Oct.
1978. .
Disposable Suction Catheter, Nursing, May 1979. .
Evaluation of selective brochial suctioning in the adult, Critical
Care Medicine, vol. 8, No. 12, 1980. .
Design and Function of Tracheal Suction Catheters, 1982. .
The New NL Tracheal Suction Catheter, Anesthesiology, 1982. .
Selective Bronchial suctioning in the adult using a curved-tipped
catheter with a guide mark, Critical Care Medicine, vol. 10, No.
11, Nov. 1982. .
Device for determining location of an endotracheal catheter tip
Critical Care Medicine, vol. 12, No. 2, Feb. 1984. .
The Beat NVM-1 Neonatal Volume Monitor, 1986 [citing U.S.
4,363,238]..
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Primary Examiner: Green; Randall L.
Assistant Examiner: Reichle; K. M.
Attorney, Agent or Firm: Foster; Lynn G.
Parent Case Text
CONTINUITY
This application is a continuation of U.S. Ser. No. 28,805, filed
Mar. 23, 1987, now abandoned, which is a continuation-in-part of
U.S. Ser. No. 917,866, filed Oct. 14, 1986, now abandoned, and a
continuation-in-part of U.S. Ser. No. 916,341, filed Oct. 7, 1986,
now U.S. Pat. No. 4,696,296, which is a division of U.S. Ser. No.
767,400, filed Aug. 20, 1985, now U.S. Pat. No. 4,638,539, which is
a division of U.S. Ser. No. 633,570, filed Jul. 23, 1984, now U.S.
Pat. No. 4,569,344.
Claims
What is claimed and desired to be secured by United States Letters
Patent is:
1. An aspirating assembly comprising:
an aspirating catheter tube comprising distal and proximal
ends;
normally-closed valve structure by which aspirating vacuum pressure
is selectively communicated to the interior of the catheter tube
for evacuation of secretions from the lungs of a patient, the valve
structure comprising a valve and a valve body in which a part of
the valve may be manually displaced, the valve body comprising
normally-closed bore means for connection at opposite ends of the
bore means respectively, to the proximal end of said catheter tube
and to a source of the vacuum pressure, the valve comprising a
one-piece element comprising (a) means simultaneously self-biasing
the valve toward a closed position, but accommodating on-going
manual displacement of part of the element counter to the self-bias
into an open position for opening said bore means across the valve
structure to accommodate communication of the vacuum pressure to
the interior of the catheter tube, (b) means sealing a portion of
the valve to the valve body for preventing entry of atmospheric
air, (c) means sealing the valve to the valve body adjacent the
bore means against fluid flow beyond the bore means within the
valve structure caused by vacuum pressure, and (d) means
accommodating fluid flow along the bore means across the valve
structure responsive to vacuum pressure when the said part of
element is displaced counter to the self-biasing to the open
position.
2. An aspirating assembly according to claim 1, the one-piece
element comprising an exposed actuator portion by which said part
of the one-piece element is manually displaced from the closed to
the open position counter to the self-biasing.
3. An aspirating assembly comprising:
an aspirating catheter tube comprising a proximal end and a distal
end;
normally-closed valve structure comprising a valve and a valve body
by which aspirating vacuum pressure is selectively communicated
along bore means to the interior of the catheter tube for
evacuation of lung secretions, said bore means comprising means for
connection to the proximal end of the catheter tube and means for
connection to a source of said vacuum pressure, the valve
comprising a self-biasing, one-piece, elastomeric element
comprising: means self-biasing the valve toward a normally-closed
position but accommodating manual displacement of at least some of
the elastomeric element from the closed to an open position counter
to the self-biasing, means sealing a portion of the valve to the
valve body for preventing entry of atmospheric air, means sealing
the elastomeric element to the valve body adjacent the bore means
against flow beyond the bore means within the valve structure
caused by vacuum pressure and means accommodating flow along the
bore means across the valve structure responsive to vacuum pressure
when the at least some of the elastomeric element is displaced
counter to the self-biasing to the open position.
4. An aspirating assembly according to claim 3 wherein the
elastomeric element further comprises an exposed actuator portion
by which said at least some of the elastomeric element is manually
displaced from the closed to the open position counter to the
self-biasing.
5. Normally-closed, valve structure by which vacuum pressure is
selectively communicated across the valve structure, the valve
structure comprising a valve and a valve body in which the valve
may be manually displaced, the valve body comprising bore means for
accomodating selective communication of vacuum pressure across the
valve structure, the valve comprising a one-piece structural
element comprising: one portion sealingly joined to the valve body
for preventing entry of atmospheric air into the valve structure, a
second portion self-biasing the structural element toward a
normally-closed position at the bore means, a third portion sealing
the valve to the valve body against flow beyond the bore means
within the valve structure caused by vacuum pressure, a
manual-displaceable fourth valving portion comprising flow
path-defining means by which the bore means is caused to be opened
for flow caused by the vacuum pressure across the valve structure
when the valving portion is displaced counter to the self-biasing
into an open position.
6. Valve structure according to claim 5 wherein the one-piece
structural element comprising a fifth portion comprising exposed
actuator means by which the valving portion is manually displaced
from the closed to the open position counter to the
self-biasing.
7. Normally-closed valve structure by which vacuum pressure is
selectively communicated across the valve structure, the valve
structure comprising a valve and a valve body in which a part of
the valve may be manually displaced, the valve body comprising
normally-closed bore means for accomodating selective communication
of vacuum pressure across the valve structure, the valve comprising
an element formed as one piece comprising (a) a part simultaneously
self-biasing the valve toward a closed position at the bore means,
but accommodating ongoing manual displacement of said part of the
element counter to the self-biasing into an open position for
opening said bore means across the valve structure to the vacuum
pressure, (b) a part sealing a portion of the valve to the valve
body for preventing entry of atmospheric air, (c) a part sealing
the valve to the valve body adjacent to the bore means against flow
beyond the bore means within the valve structure caused by vacuum
pressure, and (d) a part accommodating flow along the bore means
across the valve structure responsive to vacuum pressure when said
part of the element is displaced counter to the self-biasing to the
open position.
8. Valve structure according to claim 7 wherein the element formed
as one piece comprising an exposed actuator portion by which the
element is manually displaced from the closed to the open position
counter to the self-biasing.
9. Normally-closed valve structure by which vacuum pressure is
selectively communicated across the valve structure, said valve
structure comprising bore means for accommodating selective
communication of vacuum pressure across the valve structure and a
self-biasing one-piece elastomeric element comprising: means
self-biasing at least a portion of the elastomeric element toward a
normally-closed position but accommodating manual displacement
counter to the self-biasing of at least some of the elastomeric
element from the normally-closed position to an open position,
means sealing a portion of the elastomeric element to the valve
structure for preventing entry of atmospheric air, means sealing
the elastomeric element adjacent the bore means against flow beyond
the bore means within the valve structure caused by vacuum pressure
and means accommodating flow along the bore means responsive to
vacuum pressure when the at least some of the elastomeric element
is displaced counter to the self-biasing to the open position.
10. Valve structure according to claim 9 wherein the elastomeric
element comprises an exposed actuator by which the elastomeric
element is manually displaced from the closed to the open position
counter to the self-biasing.
Description
FIELD OF THE INVENTION
The present invention relates generally to aspiration of secretions
from the lungs of medical patients and more particularly to a
novel, single-use, disposable, aspirating device, and related
method, the device being releasibly used in conjunction with an
indwelling endotracheal tube in such a way that voluntary
respiration is accommodated, the single-use, aspirating device
functioning to remove accumulated secretions from the lungs of a
medical patient.
PRIOR ART
The relevant, known aspirating prior art falls into two categories.
The first category comprises combination ventilating and aspirating
devices left connected to the patient for relatively long periods
of time, during both intervals of use and non-use. U.S. Pat. Nos.
3,991,762 and 4,569,344 typify devices within the first category.
These are closed, involuntary ventilating systems. The presently
preferred device of the present invention is of another type, i.e.
an open, voluntary, respiratory system.
The second category comprises single-use, non-ventilating devices,
such as Davol's aspirating catheter assembly, which comprises a
sterile bag, a catheter tube within the bag and a vent fitting at
the proximal end of the assembly, which is operated to aspirate by
placing a thumb or finger over an atmospheric vent port. This type
of device has serious deficiencies, such as risk of contamination
through the atmospheric vent and awkwardness in the use thereof,
given the detached nature of such, i.e. the lack of capacity of the
device to be temporarily connected to and aligned with an
indwelling endotracheal tube. Also, coughing by the patient during
use of such a device contaminates areas outside the aspirating
device per se.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
In brief summary, the present invention overcomes or substantially
alleviates the deficiencies of the prior art by providing a
reliable, contamination-resistant, single-use disposable,
non-ventilating, medical, aspirating device, one embodiment of
which releasibly connects to and aligns with an indwelling
endotracheal tube, in such a way that voluntary respiration is
accommodated, by which an aspirating catheter tube of the device is
facilely and accurately advanced, by manual manipulation through a
collapsible, sterile, flexible envelope, into a desired lung of a
patient and selectively evacuating lung secretions through the
catheter tube and a closed and sterile, two-position,
normally-closed, manually-operable valve at the proximal end of the
device. Contamination due to patient coughing during use of device
is confined to the aspirating device itself. A related method is
provided also. Structure is also provided for restraining the
suction catheter tube in any desired extended position relative to
the remainder of the aspirating device. This structure can also
form a substantial seal against entry of contaminants into the
interior of the envelope and applies to both aspirating and
aspirating/ventilating systems. As used herein "non-ventilating"
means having no capacity to force the patient to involuntarily
ventilate.
Accordingly, it is a primary object of the present invention to
provide a novel, single-use, disposable, medical, aspirating device
and a related method.
Another paramount object is the provision of a non-ventilating,
single-use, aspirating device which is reliable and
contamination-resistant.
A further important object of the present invention is the
provision of a novel, disposable, medical, aspirating device which
is releasibly connected to and aligned with an indwelling
endotracheal tube at the time of use.
Another dominant object is the provision of a non-ventilating,
aspirating device having a novel fitting at the distal end thereof
for releasibly connecting and aligning the device with an
indwelling endotracheal tube, while accommodating simultaneous
voluntary respiration.
Still another significant object is the provision of a
non-ventilating, medical, aspirating device having a novel,
manually-operable, normally-closed valve at the proximal end
thereof by which secretions are evacuated from the lungs of a
medical patient through an aspirating catheter tube of the
device.
A further primary object of the present invention is the provision
of a novel, disposable, medical, aspirating device comprising a
manually-operable, normally-closed, contamination-resistant valve
at the proximal end of the device.
It is an additional significant object to provide a novel,
single-use, aspirating device for facilely and accurately advancing
a catheter tube thereof into a desired lung of a patient through an
indwelling endotracheal tube while simultaneously accommodating
voluntary respiration.
It is a further object of value to provide an aspirating device
which confines contamination due to patient coughing during use of
the device to the device itself.
It is another major object of this invention to provide structure
for restraining a suction catheter tube of an aspirating or an
aspirating/ventilating system in any desired extended position. It
is a further paramount object to provide structure which
substantially seals against entry of contaminants into a related
collapsible envelope and also restrains a suction catheter tube of
an aspirating or an aspirating/ventilating system in any desired
extended position.
These and other objects and features of the present invention will
be apparent from the detailed description taken with reference to
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective representation of a single-use, aspirating
device, formed in accordance with the principles of the present
invention illustrated in a detached relationship in respect to an
endotracheal tube disposed in the throat of a patient;
FIG. 2 is a perspective representation similar to FIG. 1, but
showing the single-use, aspirating device as having been force-fit
releasibly connected to the exposed end of the indwelling
endotracheal tube;
FIG. 3 is a perspective representation similar to FIG. 2 showing
the catheter tube of the single-use, aspirating device as having
been manually advanced into the respiratory system of the patient
along the hollow interior of the endotracheal tube;
FIG. 4 is an enlarged cross-sectional view of the distal fitting of
the aspirating device, taken along the lines 4--4 of FIG. 3;
FIG. 5 is an enlarged cross-sectional view of the proximal valve of
the aspirating device, taken along lines 5--5 of FIG. 3;
FIG. 6 is a fragmentary perspective representation of a second,
presently preferred proximal end valve usable with the aspirating
device of FIG. 1;
FIG. 7 is an exploded perspective of the proximal end valve of FIG.
6;
FIG. 8 is a cross-section taken along lines 8--8 of FIG. 6;
FIG. 9 is a cross-section taken along lines 9--9 of FIG. 6;
FIG. 10 is an enlarged fragmentary section of a modified distal end
fitting equipped with structure which grips the exterior of the
catheter tube to restrain it in any desired extended position in
respect to the distal end fitting;
FIG. 11 is a fragmentary section of the distal end fitting of FIG.
10, showing the catheter tube retracted from the gripping
structure;
FIG. 12 is an end view of the gripping structure taken along lines
12--12 of FIG. 11;
FIG. 13 is a fragmentary section similar to FIG. 11, showing a
modified form of the gripping structure; and
FIG. 14 is an end view taken along lines 14--14 of FIG. 13.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
Removing secretions from the tracheobronchial tree is an integral
part of the care given to patients who are intubated and receiving
mechanical or other artificial ventilation. Secretions can be
excessive in some respiratory disorders and constitute a serious
threat to the persons having such respiratory disorders. The
presence of an endotracheal tube is a hindrance to the patient's
efforts to clear secretions through natural coughing. Suction
catheters are used to clear secretions from the patient's
airway.
Reference is now made in detail to the drawings where like numerals
are used to designate like parts throughout. Particularly, FIG. 1
depicts a preferred single-use, aspirating device according to the
present invention. The device is generally deposited 10. The device
10 is intended for a single use and is not left connected or
indwelling for repeated use over a protracted interval of time. The
aspirating device 10 broadly comprises an aspirating catheter tube,
generally designated 12, which extends along substantially the
entire axial length of the device 10 and is encased within and
substantially sealed by a transparent tube of flexible film
comprising synthetic resinous material, such as medical grade
polyethylene film. The tubular sleeve or envelope 14 prevents
contamination of the encircled catheter tube 12. The envelope 14 is
manually-collapsed, typically between the thumb and index finger of
the attending clinician or practitioner or the like in order to
manipulate the catheter tube 12, as hereinafter more fully
described.
The aspirating device 10 further comprises a fitting 16 disposed at
the distal end of the device 10. The fitting 16 makes the present
system an open system in that, when coupled to the exposed end of
the endotracheal tube, voluntary respiration is accommodated
through the interior of the bell-shaped, cough guard fitting 16 and
the endotracheal tube. The distal end of the collapsible sleeve or
envelope 14 is firmly secured and sealed to the fitting 16 by a
force-fit collar 18.
The aspirating device 10 further comprises a normally-closed,
manually-operable valve, generally designated 20. Valve 20 is
carried at the proximal end of the device 10 and is secured to the
proximal end of the catheter tube 10. The proximal end of the
collapsible sleeve or envelope 14 is firmly and sealingly secured
to the valve 20 by an interference-fit collar, generally designated
22.
The aspirating device 10 is non-ventilating and intended to be
releasibly and alignably joined to the exposed end of an indwelling
endotracheal tube, generally designated 24, only at the time of
use. The term "non-ventilating" is intended to mean having no
capacity to force the patient to involuntarily ventilate. The
device 10 is intended to be removed from the patient when a single
use of the device 10 has been completed. The structure and the
placement of the endotracheal tube 24 is conventional and requires
no further description here. The endotracheal tube 24 is
conventionally equipped with a fitting, generally designated 26, at
the exposed proximal end thereof, which is force-fit into the
proximal end 25 of the endotracheal tube 24 and presents central
radially-extending tabs 27 and an exposed outwardly-directed,
cylindrical extension 28. The fitting 26 has a hollow passage
axially disposed along its interior. The endotracheal tube 24 is
illustrated as having been properly placed through the mouth and
the throat of a patient, generally designated 30.
The catheter tube 12 is controlled solely by manual manipulation
thereof through the envelope and is at no time subject to
mechanical manipulation. The aspirating catheter tube 12 has
sufficient strength to prevent buckling, bending and twisting of
the catheter tube which would otherwise occlude or tend to occlude
the catheter tube. The aspirating catheter tube 12 is formed of a
suitable synthetic resinous material, such as a medical grade
transparent polyvinyl chloride and further comprises an annular
wall essentially of uniform thickness throughout having uniform
inside and outside diameters. The outside diameter is selected to
comfortably pass through the endotracheal tube and throat and into
either lung of the patient while accommodating simultaneous
voluntary respiration by the patient through the hollow bell
housing of the fitting 16 and the interior of the endotracheal
tube.
The catheter tube 12 comprises a distal end 32, which is inserted
into the lung of the patient 30. The distal end 32 is equipped with
one or more intake ports 33 (FIG. 4) by which secretions existing
within the lung of the patient may be drawn into the hollow
interior of the catheter tube 12 and thence along the length
thereof and across the valve 20, as hereinafter more fully
explained. The proximal end 34 of the catheter tube 12 is anchored
to the valve 20 in a manner explained in greater detail later.
The catheter tube 12 is adapted to be reciprocally and, if desired,
rotationally displaced to and fro through the fitting 16 generally
along the axis of the device 10 and along the axis of the
endotracheal tube 26, for purposes yet to be more fully explained.
The outside diameter of the catheter tube 12 is correlated with the
transverse size of the passageway through the fitting 26 so that
the distal end 32 of the catheter tube 12 can freely pass through
the fitting 26 and along the hollow interior of the endotracheal
tube 24.
Preferably the length of the flexible sleeve or envelope 14 is
selected so that when in assembled condition, and with the envelope
14 fully extended, the distal tip of the catheter tube 12 will be
disposed within the hollow interior of the fitting 16.
As best illustrated in FIG. 4, the fitting 16 is substantially
hollow and comprises a body of material which extends axially but
is transversely elongated in one plane only.
More specifically, the fitting 16, at the distal portion thereof
comprises a flattened shell 40, illustrated as having a uniform
wall thickness throughout, which defines an external surface 42 and
a hollow interior 44. The shell is arcuately enlarged at opposed
sites 46 and 48. The arcuate enlargements 46 and 48 together define
a common interior diametrically enlarged opening therebetween which
is substantially identical to the diameter of the projection 28 of
the endotracheal fitting 26. Thus, the fitting 16 is force-fit at
arcuate sites 46 and 48 over the projection 28 of the endotracheal
fitting 26, as best illustrated in FIGS. 2 and 3. The nature of the
interference fit is such as to permit intentional separation
thereafter but to avoid inadvertent separation.
The distance to which the fitting 16 can be forced upon the
projection 28 is limited by engagement of the outer edge 50 thereof
(FIG. 1) with the interior shoulders 52 and 54 (FIG. 4) at the end
of the wall enlargements 46 and 48 of the fitting 16. The shell 40
is convergently constricted at central site 56. The shell 40 there
integrally emerges with a forwardly directed interior annular boss
58. Boss 58 extends into the hollow interior 44 of the shell 40 and
has an inside uniform diameter at surface 60 which is substantially
the same as the outside diameter of the catheter tube 12. Thus,
bore 60 resists, at atmospheric pressure, entry of air or
contaminants. However, when the catheter tube is advanced causing
the envelope to be compressed, the above-atmospheric pressure
within the envelope forces evacuation of the air within the
envelope through the bore 60. One or more minute axially-directed
grooves can be placed in the surface defining the bore 60 to
provide for such evacuation, if desired. At the same time the
catheter tube 12 can be manually reciprocated and rotated in
respect to the surface 60. See FIG. 4. The fitting 16, because it
is part of a single use device, is ordinarily not provided with
structure by which the exterior surface of the catheter tube may be
cleansed via irrigation as it is withdrawn from the respiratory
system of the patient.
The shell 40 is also integral with a rearwardly-directed,
generally-annular projection 62. Annulus 62 terminates in a
rearwardly-exposed edge 64, while the shell 40 terminates in a
forwardly-exposed edge 66. The annular 62 has an outside diameter
at surface 68 and presents a generally hollow interior 70. Surface
68 is interrupted by two, closely-spaced, outwardly-directed ribs
83 and 85. The annular 62 is adapted for use in joining the fitting
16 to the distal end of the envelope 14 using the collar 18.
The collar 18 is preferably of polypropylene and essentially an
annular ring comprising forward and rearward flat edges 72 and 74,
each lying in a plane transverse to the axis of the fitting 16. The
collar 18 further comprises an exterior, arcuate surface 76 and a
wall which is of substantially uniform thickness. The ring or
collar 18 further comprises an interior, generally-annular surface
78, which is interrupted by one inwardly-directed, annular radial
rib 82. The rib 82 is ultimately force-fit into the groove between
annulus ribs 83 and 85. More specifically the ribs 82, 83 and 85
are sized, located and configured so that when the distal end of
the envelope 14 is positioned essentially contiguously along the
exterior surface 68 of the annulus 62, with the collar 18
circumscribing the envelope 14 slightly to the rear of the annulus
62, the collar 18 can be manually force-fit by axial displacement
thereof over the top of the distal end of the envelope 14 and the
annulus 62 so as to cause the annular rib 82 to be located between
ribs 83 and 85 to compressively bite tightly against the envelope
14 in three closely spaced annular locations to secure and seal the
envelope to the fitting 16, as illustrated in FIG. 4. As a
consequence, bacteria and other contaminants are prevented from
entering the flexible envelope prior to use and from leaving the
envelope after use.
It is to be appreciated that the fitting 16 and collar 18 can be
eliminated, where a highly simplistic, economical aspirating device
is desired. In that case the distal end 32 of the envelope 14 would
be free prior to use with the catheter tube disposed within the
envelope 14. To insert this type of device, the operator merely
manually advances the distal end 32 of the catheter tube 34 out of
the envelope 14 into the hollow of the endotracheal tube and thence
into the desired lung of the patient.
With reference to FIG. 5, the aspirating, manual-control valve
assembly 20 comprises a valve body generally designated at 90, a
plunger, generally designated at 92 and a valve member, generally
designated 94, for which functions both as a seal and as a return
spring. Valve 20 is not vented at any time to the atmosphere.
The valve body 90 is preferably of one-piece, molded construction
and comprises an axial nipple 96, which is press fit connected to a
hose or the like and thence to a conventional vacuum source 98
(FIGS. 2 and 3). Preferably, body 90 is formed of ABS. The nipple
96 has a hollow interior 100, shown as being of uniform cylindrical
diameter. The nipple 96 comprises a stepped exterior comprising a
larger diameter portion 102 and a smaller diameter proximal portion
104. A tapered shoulder 106 integrally joins the cylindrical
surface 102 and 104 at essentially a central location.
The cylindrical portion 102 joins a transverse hollow body portion
108 which comprises a cylindrical wall 110. Wall 110 defines a
hollow cylindrical interior 112. The hollow interior 112 of the
transverse wall 110 is normal and opens into the hollow bore 100 of
the nipple 96.
The transverse wall 110 merges with a forwardly-directed annulus
114. The wall of the annulus 114 is enlarged at one side at
abutment 116, which defines shoulder 118. The wall of annulus 114
essentially closes one end of the bore 112. Wall of annulus 114
terminates in an edge 122. Concentrically within the wall of
annulus 114 is disposed a boss 124. A hollow interior 120 is
defined within the boss 124. The hollow of the catheter tube 12 is
in open communication with the hollow interior 120 of the
annulus.
The interior diameter of the boss, at site 126 is substantially the
same in diameter as the outside diameter of the catheter tube 12.
The catheter tube, as illustrated in FIG. 5, is placed
concentrically within the hollow 120 and secured by suitable
bonding agent, adhesive or the like at site 126. Thus, the proximal
end of the catheter tube 12 is rigidly anchored to the valve 20.
Accordingly, the hollow interior of the catheter tube 12 is
directly in fluid communication with one end of the hollow bore 112
of the wall 110. The wall 110 integrally merges with the boss 124,
the boss terminating in a cantilevered edge 128 also disposed in a
plane transverse to the axis of the catheter tube 12.
The annulus 114 comprises an external cylindrical surface 130,
which is interrupted by a radially-directed outwardly-projecting
rib 82'. When the proximal end of the sleeve or flexible envelope
14 is contiguously placed along the outside surface 130, with the
collar 22 surrounding the envelope 14 to the right of the annulus
114 (as viewed in FIG. 5), the ring or annulus 22, which is
substantially similar to collar 18 and has been so numbered, is
displaced and thereby caused to be force-fit over the proximal end
of the envelope 14 causing internal ribs 83' and 85' of the collar
to be located on opposite sides of the ribs 82'. Thus, the three
closely spaced ribs compressively bite against the contiguous
portion of the envelope 14 and force the same tightly against the
surface 130 of the annulus 114. In this way the envelope 14 is
firmly secured and sealed against to the valve 20 against
inadvertent release.
The transverse cylindrical wall 110, at the end thereof opposite
abutment wall 116, terminates in a radially-directed, cup-shaped
flange 140. Flange 140 serriatum comprises an exposed, annular
surface 142 which joins surface 108, a shoulder 144, a further
annular surface 146 and an arcuate edge 148. The edge 148 and the
annular surface 146 comprise part of an annular lip 150 disposed
parallel to the bore 112.
The lip 150 terminates in a transversely directed edge 152. Edge
152 merges through 90 degrees into an annular surface 154, which in
turn merges through 90 degrees with a flat surface 156. Surface 156
merges with the wall 110 at the transverse bore 112. Surface 154
and 156 create a dish-shaped recess. Surface 156 also is
interrupted by an annular, recessed groove 158.
The recess in the described flange, formed by surfaces 154 and 156
receives part of a valve member comprising seal/spring member 94.
More specifically, the seal/spring member 94 comprises a flange
160, which is sized and shaped to be contiguously received at wall
surfaces 154 and 156 and within groove 158 in such a fashion that
the upper surface thereof is flush with edge surface 152. A
suitable adhesive or the like can be placed at the interface
between the flange 140 of the valve body 90 and the flange 160 of
the seal/spring member 94 to secure the two components together.
The flange 160 has a central opening at site 162.
The seal/spring member 94 is preferably made of highly resilient,
relatively soft synthetic material, such as silicone rubber which
has a significant memory to accommodate the required sealing and
spring functions. The seal/spring member 94 comprises a hollow
annulus 164 which integrally merges with the flange 160 and
comprises an inside circular diameter at surface 166 and an outside
diameter at cylindrical surface 168.
The diameter at surface 166 is the same size and aligned with the
central opening 162 in flange 160. The diameter of the outside
cylindrical surface 168 is less than the diameter of the bore 112
of the valve body cylindrical wall 110. This creates an annular
space between the surfaces 112 and 168. The cylindrical wall 164
integrally merges, at a location remote from the flange 160 with a
piston head 170. The piston wall 170 is integral with the
cylindrical wall 164, being formed as one piece therewith and
comprises a blunt exposed end 172 and an annular edge 174. Together
walls 164 and 170 define a blind bore. The diameter of the annular
edge 174 in a non-stress condition is enlarged, being slightly
larger than the diameter of the bore 112 so that the piston wall
170 at edge 174 is force-fit into the position illustrated in FIG.
5.
The position of FIG. 5 is the non-actuated, normally closed,
unstressed condition of the valve 20. Thus, it can be seen that the
length of the cylindrical wall 164 is selected so that the piston
wall and the seal thereof is disposed reciprocally but sealingly
against the interior surface of the wall 110 of bore 112 at a site
between the hollow interior 100 of the nipple 96 and the hollow
interior 120 of the boss 124. Thus, in the unstressed, at rest
condition illustrated in FIG. 5, the valve 20 prevents vacuum
available at source 98 for reaching the interior of the catheter
tube 12. The valve arrangement in this condition and position and
in all other positions is sealed and unvented which prevents entry
of contaminants into the hollow of the catheter tube or into the
hollow of the envelope 14.
The plunger 92 comprises an elongated cylindrical extension 180,
which comprises a blunt edge 182 and an exposed end which is
integrally connected at site 184 to a disc-shaped handle or
actuator 186. The exterior diameter of the cylinder 180 is selected
so as to be slightly larger than the at rest interior diameter at
surface 166 of the wall 164. Accordingly, when the cylinder 180,
made of rigid plastic material, is inserted into the blind bore
created by the cylindrical wall 164 and the piston wall 170, a
stretch-fit relationship is created wherein the material of the
wall 164 radially compressively grips the cylinder 180.
When the clinician, or doctor grasps the catheter tube 12 between
the fitting 16 and the valve 20 by collapsing the envelope 14 upon
the catheter tube, with the device 10 connected to the endotracheal
tubes as illustrated in FIG. 2, the clinician manually advances the
catheter tube through the fittings 16 and 26 and down the
endotracheal tube 24 into one of the lungs of the patient with the
distal end of the catheter tube 12 properly positioned in the
selected lung so that the port or ports 33 thereof are placed
appropriately in accumulated secretions in the lung. With the valve
20 appropriately conventionally connected to the vacuum source 98,
the secretions are evacuated from the lung through the hollow
interior of the catheter tube 32 and the valve 20 when the operator
depresses the actuator 186 from the position illustrated in solid
lines in FIG. 5 to the position illustrated in dotted lines in FIG.
5, counter to the memory of the material from which the seal/spring
member 94 is formed. This fluid-connects the hollow bore 112 to
both the hollow 100 of the nipple 96 and the hollow 120 of the boss
124. Thus, the force of the vacuum from source 98 is communicated
to the hollow interior of the catheter tube 12. The valve 20 is
completely sealed against loss of the vacuum pressure applied to
the lung of the patient.
When the secretions within the lung have been appropriately
evacuated, the second lung can be evacuated in a similar fashion,
if desired. In any event, when a single use of the device 10,
either in one or both lungs, has been completed, the user releases
the valve actuator 186 causing the memory of the seal/spring member
94 to return the valve 20 to its normally closed position. The
catheter tube 12 is then manipulated by collapsing the envelope 14
upon the catheter tube, will remove the catheter tube 12 from the
endotracheal tube 24 until the full length of the catheter tube 12
is substantially disposed within the envelope 14. The fitting 16 is
axially removed from the endotracheal projection 28 and the valve
20 is disconnected from the vacuum source 98. The device 10 is then
discarded.
Coughing by the patient during use of the device 10 does not
contaminate areas outside the aspirating device per se.
In lieu of the valve fitting 20, the valve fitting illustrated in
FIGS. 6-9 may be utilized. This valve fitting is generally
designated 200. The valve fitting 200 comprises a valve body 201, a
valve member 270 and a retainer cap 272. See FIG. 7. The valve body
201, preferably formed as one piece by injection molding, comprises
a first cantilevered end 202 by which one end of the envelope 14 is
secured at collar 22. End 202 of the valve fitting 200 is identical
to the end of the valve fitting 20 which connects to the envelope
34 at collar 22, as illustrated in FIGS. 1-3 and 5. End 202 is
correspondingly numbered in FIGS. 6-9. Accordingly, no further
description of end 202 of fitting 200 is needed.
The valve body 201 comprises a central portion 204, which defines a
linear passageway 206, centrally located and axially directed.
Passageway 206 is aligned with and is illustrated as having a
diameter substantially the same as the interior diameter of the
catheter tube 34. Axial passageway 206 is subdivided into two
sequential sections by a vertically-directed rectangular slot 208.
Vertically-directed, rectangular slot 208 comprises an opening 210
at top surface 212 of the central portion 204. Surface 212 is
essentially circular and forms the bottom of a deflection chamber
or compartment 214, as explained hereinafter in greater detail.
The slot 208 is vertically elongated and extends, as illustrated in
FIG. 8, downwardly to a location substantially below the end 202 of
the valve fitting 200. The rectangular slot 208 has a predetermined
uniform thickness 234 (FIG. 8) and a downwardly tapered width 236
(FIG. 9). The interior bottom surface of the vertical rectangular
slot 208 comprises part of a rectangular, horizontally-directed
wall 218. Wall 218 terminates in exposed, rectangular, exterior
surface 220 and merges with vertically-directed, transverse walls
222 and 224 and downwardly-tapered side walls 223 and 225,
respectively. The wall 222 is defined by an interior surface 226
and an exterior surface 228. Wall 224 is defined by interior
surface 230 and exterior surface 232. Wall 223 comprises interior
surface 235 and exterior surface 237. Wall 225 comprises interior
wall surface 233 and exterior wall surface 231. As illustrated, the
walls 218, 222, 224, 223 and 225 are illustrated as being of
uniform thickness throughout.
Preferably, the valve body member 201 is injection molded of
shape-retaining, synthetic resinous material, such as rigid
ABS.
The relatively massive central portion 204 comprises an integral,
upwardly-directed, annular ring or boss 240. Boss 240 comprises an
annular wall 242, illustrated as being of substantially uniform
thickness throughout. Wall 242 comprises an annular interior
surface 244, forming part of the deflection chamber or compartment
214, and an external surface 243, which is generally cylindrical
but interrupted by a horizontally-directed radial lip 246,
illustrated as being generally of rectangular cross-section.
Annular wall 242 terminates in a blunt upper edge 247.
The relatively massive central portion 204 also comprises a
proximal end portion, generally designated 250. End 250 is
cantilevered generally away from the patient from the central
portion 204 and centrally defines the longer of the two sections of
the axial bore 206. The external surface of the end 250 comprises a
series of stepped annular sections to provide a better grip when
tubing connected to a vacuum source is force-fit over the exterior
of the fitting 250. These stepped annular surfaces are sequentially
designated by the numerals 252, 254, 256 and 258, respectively.
Radially-directed shoulders 260, 262 and 264 are respectively
interposed seriatum between the indicated annular surfaces 252,
254, 256 and 258. The end 250 terminates in a blunt
transversely-directed edge 266.
The valve member 270 functions not only to open and close the valve
fitting 200 but acts as its own return spring. Valve member 270 is
formed of silicone rubber or the like which has characteristics of
substantial elasticity, substantial memory and substantial
compressibility. Valve member 272 comprises an inverted cup-shaped
spring member 274. Spring member 274 comprises a disc-shaped
diaphragm top 275 which comprises a top surface 276 and a bottom
surface 278. The disc-shaped top 275 is illustrated as being of
uniform thickness. Disc-shaped top 275 merges at its perimeter with
a downwardly-directed annular flange or lip 280, illustrated as
being of uniform thickness throughout and comprising outside and
inside wall surfaces 281 and 283. The lip 280 is the structure by
which the valve member 270 is held in the assembled position
illustrated in FIG. 8. The disc-shaped top 275 specifically
functions as a diaphragm return spring.
Integral with the disc-shaped top 275 is a centrally-disposed,
upwardly-projecting, cylindrical actuator 282. Actuator 282
terminates in a blunt exposed upper edge 284 and has enough mass
and structural integrity so that it does not deflect from
side-to-side when depressed.
Also integral with the disc-shaped top 275 is a
downwardly-directed, generally-rectangular, flat valve plate 286.
Valve plate 286 comprises front and back flat surfaces 288 and 290,
an edge 292 which runs through 180 degrees from and to bottom
surface 278. The edge 292 comprises rounded corners 294 and 296
adjacent the downwardly-directed apex 298 of the edge 292.
The valve plate 286 also comprises an aperture 300 of predetermined
size and location spanning between the surfaces 288 and 290. As
illustrated, the aperture 300 may be located essentially
equidistant between the disc surface 278 and the end 298.
The width end thickness of the valve plate 286 are predetermined so
as to be just slightly less than the thickness 234 and slightly
less than the width 236 of the slot 208. The vertical length of the
valve plate 286 is, in an unstressed state, formed so as to extend
only partly along the length of the slot 208 so that the aperture
300 is clearly out of alignment with the bore sections 206 and the
valve plate 286 is axially compressed. The dimensional relationship
between the valve plate 286 and the slot 208 is, therefore, such
that a seal is created between the surface 290 of the valve plate
286 and the slot surface 20. Thus, when the valve plate 286 is in
the unstressed position illustrated in FIG. 8, any vacuum pressure
within the bore 206 at the end 250 is isolated by the valve plate
286 from the interior of the catheter tube 34.
The retainer cap 272 is preferably formed of shaped-retaining,
synthetic resinous material and comprises an upper, horizontally
disposed wall 310 of uniform thickness comprising a top surface 312
and a bottom surface 314. The wall 310 is interrupted by central
aperture 316, the diameter of which is larger than the diameter of
the cylindrical actuator 282 so that the actuator 282 may
reciprocate up and down loosely through the aperture 316. The
horizontal wall 310 merges with an annular downwardly directed
flange 320 which is integral with the annular wall 310 and extends
radially downwardly and comprises exposed annular surface 322 and
interior generally annular surface 324. An annular groove 326 is
disposed in a wall 320 at surface 324 near the lower edge 328, and
sized and located so as to snugly fit over the flange 246 and
retain the retainer 272 in a snap-fit assembled position as
illustrated in FIG. 8 against inadvertent removal. This retains the
wall 280 of the valve member 270 in its assembled condition.
Note that downwardly-directed radial flange 280 is sized and shaped
to fit compressively between the space created between the walls
242 and 320 with the deflectible disc-shaped top 275 spanning
across the cavity 214. Thus, the downward flange or lip 280 is
trapped and held in the assembled position by the retainer cap 272
against inadvertent release.
The length of the cylindrical actuator 282 is preferably selected
so that manual depression of the same (against the memory of the
silicone rubber material from which the disc-shaped top spring
member 275 is made) may continue downwardly until the upper blunt
surface 284 is essentially flush with the surface 312 of the
retainer 272. This forces the valve plate 286 downwardly into the
slot 208 a distance sufficient to bring the aperture 300 of the
valve plate 286 into alignment with the two bore segments 206.
Thus, the vacuum is communicated through the two bore sections 206,
the aperture 300 and the hollow interior of the catheter tube 34 to
remove secretions from a selected lung of the patient.
Release of air within the chamber 214 and the lower portion of the
slot 208 during the mentioned actuation is accommodated along the
edges of the valve plate 286. Also, the valve 200, being a normally
closed valve and being entirely manually operable, means that the
valve is in its "on", depressed condition only so long as manual
pressure is retained at the actuator 282. Thus, the operator will
maintain the application of the vacuum pressure to the hollow
interior of the catheter tube for removal of secretions from the
selected lung, only so long as the procedure is efficacious for
such removal. When the secretions have been removed, the operator
merely releases the actuator 282 and the memory of the material
from which the disc-shaped top spring member 275 is made will cause
the valve member 270 to return to the unstressed, at rest position
illustrated in FIGS. 8 and 9. When the catheter tube is removed
from the respiratory system, the fitting 16, if part of the device,
is uncoupled from the endotracheal tube and the aspirating device
discarded.
Reference is now made to FIGS. 10-12 which illustrate gripping
structure, generally designated 340. Gripping structure 340
comprises part of the distal end fitting 16', which is
substantially identical to distal end fitting 16, shown FIG. 4, and
heretofore described. Those parts of fitting 16' which are
identical to the corresponding parts of fitting 16 has been so
designated by numerals in FIGS. 10-12. The bore 60' is somewhat
larger than the illustrated bore 60 of fitting 16 so that a
substantially loose concentricity will exist between the distal end
32 of the catheter tube 34 and the bore 60', when the catheter tube
is within the bore 60' either retracted or extended.
The gripping structure 340 comprises a series of angular fingers
342, which are created by a series of radially-directed slits 344,
as best illustrated in FIG. 12. Thus, the fingers 342, being formed
of relatively thin, yieldable-thin, synthetic resinous material,
preferably as one piece with fitting 16', may be forcibly displaced
from the radially-disposed, unstressed orientation of FIG. 12 to
the essentially axially-disposed deflected orientation of FIG. 10.
In the orientation of FIG. 10, the slits 344 open so that air from
within the associated collapsible envelope 14 is readily evacuated
as the catheter tube 34 is advanced through the housing 16' and the
hollow of the endotracheal tube into the respiratory system of the
patient. However, the fingers 342, because of the memory of the
material from which each is formed, collectively exert a
radially-directed compressive force upon the exterior surface of
the catheter tube 34 while at the same time frictionally engaging
the exterior surface of the catheter tube 34. Thus, the clinician,
doctor or the like, responsible for manipulating the catheter tube
34 may advance, or retract the catheter tube 34 to a precise
extended position through the gripping structure 340 and the
fingers 342, thereafter, will retain the catheter tube 34 in the
selected, extended position against inadvertent relative
displacement of the catheter tube 34 in respect to the fitting
16'.
As best illustrated in FIGS. 11 and 12, the gripping structure 340
essentially closes into a substantially sealed, radially-directed
composite structure prior to the advancement of the catheter tube
34 and after retraction of the catheter tube as well. Thus, the
gripping structure 340, when closed as illustrated in FIGS. 11 and
12, functions to substantially seal against undesired entry of
contaminants into the hollow of the collapsible envelope 14.
Reference is now made to FIGS. 13 and 14 which illustrate a
modified gripping structure, generally designated 350. Gripping
structure 350 comprises a plurality of rounded fingers 352, which
are spaced one from another in their unstressed radial orientation
by open slots 354. The fingers 352 function in substantially the
same fashion as previously described fingers 342. However, with the
existence of the open slots 354, the gripping structure 350 does
not per se form a seal when the catheter tube 34 is withdrawn or
prior to its advancement. Accordingly, it is preferred that the
central bore 60" have a diameter just slightly greater than the
diameter of the catheter tube so that entry of contaminants between
the two is either prevented or substantially alleviated.
The invention may be embodied in other specific forms without
department from the spirit or essential characteristics thereof.
The present embodiments, are, therefore, to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description, and all changes which come within the
meaning and range of equivalence of the claims are therefore to be
embraced therein.
* * * * *